False/Negative Rate of Lung Percutaneous Needle Biopsy

NCT00638352 | Completed

• 1 other identifier: SUNYUMU 5334
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Needle biopsy is a way of determining whether a lung mass is cancerous or benign. Its accuracy was established by research in which patients underwent fine needle aspiration, a kind of needle biopsy that yields samples for cytology (similar to the way a pap smear or a fluid sample would be evaluated for malignant cells). This kind of needle biopsy may supplemented or replaced by core needle biopsy, which yields samples for histology (similar to surgical tissue samples but on a smaller scale) rather than for cytology. Core needle biopsy is believed to be helpful particularly in obtaining a diagnosis in patients who have a lung mass that their doctors think is cancerous but is, in fact, benign. In spite of the advances in needle biopsy, however, there are patients who do receive a pathology report indicating no evidence of cancer but whose lung mass actually is cancerous. The fraction of such patients, among all patients who have no evidence of cancer according to the biopsy, is called the "false negative rate." It is approximately 25% for needle biopsies that consist of fine needle aspiration alone. The false negative rate for needle biopsies that include core biopsy samples is not known. We want to examine the accuracy of needle biopsy in patients who had core samples taken from a lung mass in addition to, or in place of, fine needle aspiration. In this study we will focus on such patients who had no evidence of cancer according to the biopsy, to determine how many actually had a cancer that was missed by the biopsy. To accomplish this goal, we will need to review the medical records of these patients for one of two things: either a definitive diagnosis of the lung mass by some other means (for example, surgical biopsy), or by seeing how the patient does over a period of time (usually in conjunction with medical imaging tests such as chest x-rays or chest CT scans). To establish that a lung mass is benign by observing a patient over time, it is necessary to show that the lung mass disappears, becomes smaller, or remains unchanged in size for 2 years.

Conditions

Lung Neoplasm

Keywords

Core Biopsy; Needle Biopsy; Percutaneous Biopsy

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine the false negative rate of PTNB procedures that include core tissue samples, and to compare it to the historical false negative rate of PTNB with FNA only.

  2 years

Secondary Outcomes (1)

• To determine the sensitivity of PTNB procedures that include at least one core tissue sample, for the diagnosis of malignancy.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will review medical records to identify patients who underwent percutaneous needle biopsy of a lung mass between 5/1/01 and 10/30/04. If the pathology report indicates that the the biopsy showed no evidence of malignancy, we will examine the medical record for a "gold standard" diagnosis of the lesion in question, including the pathology result from a surgical resection or a repeat biopsy, or imaging follow-up demonstrating regression of the lesion (or size stability for at least 2 years), or clinical follow-up for at least 2 years.

You may qualify if:

• subjects who underwent percutaneous needle biopsy of a lung mass during the study period of 5/1/01 to 10/30/04

You may not qualify if:

• subjects will be excluded if at least one core sample was not obtained in the course of the biopsy.
• subjects who had a pathology sample read as "insufficient for diagnosis"
• subjects who underwent needle biopsy only for infection, to identify a causative organism

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ernest Scalzetti, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: March 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)